PFIZER ITALIA S.R.L. -
Modifiche secondarie di un'AIC di medicinale per uso umano, apportata ai sensi del d.lgs. 219/2006 e s.m.i. Ai sensi della Determinazione AIFA 25 agosto 2011 si informa dell'avvenuta approvazione delle seguenti modifiche apportate in accordo al regolamento (CE) 1234/2008: Titolare AIC: Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina Specialita' medicinale: VINCRISTINA PFIZER ITALIA Confezioni e numeri di AIC: tutte le confezioni 033329/M Codice pratica: C1A/2013/169 Procedura n. IT/H/138/01/IA/013/G Grouping di variazioni di tipo IA: N.7 variazioni B.III.2-z al fine di conformarsi alla Farmacopea europea, rimozione dei riferimenti ai metodi e ai numeri dei tests interni. Titolare AIC: Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina Specialita' medicinale: VINCRISTINA PFIZER ITALIA Confezioni e numeri di AIC: tutte le confezioni 033329/M Codice pratica: C1B/2013/562 Procedura n. IT/H/138/01/IB/014 Variazione di Tipo IB n. C.I.3-a - Attuazione delle modifiche richieste dall'autorita' nazionale competente in seguito alla valutazione di una misura restrittiva urgente per motivi di sicurezza, dell'etichettatura di una classe, di una relazione periodica aggiornata relativa alla sicurezza, di un piano digestione del rischio, di una misura di controllo/di un obbligo specifico, di dati presentati in virtu' degli articoli 45 e 46 del regolamento (CE) n. 1901/2006 o di modifiche volte a riflettere un RCP (riassunto delle caratteristiche del prodotto) di base elaborato da un'autorita' competente a)Attuazione della o delle modifiche di testo approvate per le quali il titolare dell'autorizzazione all'immissione in commercio non presenta nuove informazioni complementari. Specialita' medicinale: Xanax Confezioni e Numeri di AIC: 0,25mg - 20 compresse AIC n. 025980057 0,50mg - 20 compresse AIC n. 025980069 1mg - 20 compresse AIC n. 025980071 Titolare AIC: Pfizer Italia S.r.l., Via Isonzo 71, 04100 Latina Codice pratica: n. N1B/2012/2490 Variazione B.II.b.1 e) Tipo IB - Aggiunta del sito Pfizer Pharmaceuticals LLC, Road #2, Km. 58.2, Barceloneta, Puerto Rico (Pfizer...
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